FDA Adverse Event
Other
Summary report: N
ARJO AMBULIFT BSQ
MDR report key: 61050
·
Received January 3, 1997
Report
- Report Number
- 1922538-1997-00003
- Event Type
- Other
- Date Received
- January 3, 1997
- Date of Event
- December 16, 1996
- Report Date
- January 2, 1997
- Manufacturer
- ARJO MANUFACTURING CO.
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE FOLLOWING IS A CLOSE OUT REPORT BY THE FOREIGN REPORTER. INVESTIGATION: A WHEEL ON THE SUB-CHASSIS WAS ALSO FOUND TO BE LOOSE AND HAD FELL OUT, THIS WAS RE-TIGHTENED. THE BACK REST SCREWS WERE LOOSE AND TWO WERE MISSING ALTOGETHER. OBSERVATIONS: 5 OTHER DEVICES
Description of Event or Problem · 1
THE PICK UP HOOK OF THE JIB HAS BECOME DEFORMED AND ALLOWED THE CHAIR TO BE DISLODGED AS A PT WAS BEING HOISTED INTO THE BATH. THE CHAIR AND PT DID NOT FALL TO THE FLOOR AND INJURY HAS NOT OCCURRED. ONE PERSON INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARJO AMBULIFT BSQ | PATIENT HOIST | FSA | ARJO MANUFACTURING CO. | AB1402 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |